跳至主要内容
临床试验/NCT04576182
NCT04576182招募中不适用

Investigating Mechanisms of Change in Supportive-Expressive vs. Emotion-Focused Treatment of Depression Using a Personalized Treatment Approach: The Case of the Theories of Weakness vs. Strength

University of Haifa1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2020年11月29日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
124
试验地点
1
主要终点
Weekly change in Hamilton rating scale for depression (HRSD)

研究概览

简要总结

This study will explore the mechanisms of change that are activated when individuals receive a treatment that targets their weakness and the mechanisms activated when the treatment capitalize on their strength. Patients will be assigned to one of two types of psychotherapies in treating people with a major depression disorder, expressive-supportive vs. emotion-focused treatment. Their ability to benefit from treatment based on their pre-treatment levels of insight and emotional processing will be examined. This is a four-month protocol, with a 2 year follow up period.

详细描述

One hundred and twenty-four patients suffering from major depressive disorder will be randomized to participate in 16 sessions of either supportive-expressive therapy or emotion-focused therapy. The two treatments are theorized to differ in their main mechanism of change: supportive-expressive therapy places emphasis on insight as its main mechanism of change, and emotion-focused therapy places emphasis on emotional processing as its main mechanism of change. Both can serve as strength- or weakness-focused treatments, based on the patient's baseline levels of insight and emotional processing. Importantly, this study will employ multiple complementary methods, which will include session-by-session self-report questionnaires from both patient and therapist, as well as interdisciplinary measures based on hormonal and acoustic measures, cognitive tasks, clinician interviews, and behavioral coding systems to complement the self-report measures. In addition, prior the beginning of treatment patients will complete diaries via mobile survey application. The findings will contribute to the research on personalized mechanisms of change and can help clinicians focus on more efficient treatment delivery, adapted to given subpopulations of patients, according to their strengths and weaknesses. If a mechanism most likely to stimulate change for a subpopulation is identified, a corresponding treatment can be chosen that is most likely to activate that particular mechanism and by that improve the rate of patients' respondent to treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Double Blind (participants, outcome assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Meeting major depressive disorder diagnostic criteria using the structured clinical interviews for Diagnostic and Statistical Manual of Mental Disorders-5 and scoring more than 14 on the 17-item Hamilton rating scale for depression at two evaluations (one week apart) (Hamilton, 1967).
  • If on medication, patients' dosage must be stable for at least three months prior to entering the study, and they must be willing to maintain stable dosage for the duration of treatment
  • Age between 18 and 65
  • Hebrew language fluency
  • Provision of written informed consent.

排除标准

  • Current risk of suicide or self-harm
  • current substance abuse disorders
  • current or past schizophrenia or psychosis, bipolar disorder, or severe eating disorder requiring medical monitoring
  • history of organic mental disease
  • currently in psychotherapy

结局指标

主要结局

Weekly change in Hamilton rating scale for depression (HRSD)

时间窗: up to 16 weeks.

A 17-item clinically administered measure assessing the severity of depression. Higher scores indicate worse outcome.

次要结局

  • Weekly change in Beck Depression Inventory (BDI)(up to 16 weeks)
  • Weekly change in Outcome Questionnaire (OQ)(up to 16 weeks)
  • Trajectories of change in Inventory of Interpersonal Problems (IIP-32)(At intake and 6 times during the treatment (weeks 1, 2, 4, 8, 12, 16))
  • trajectories of change in Quality of Life Enjoyment and Satisfaction- Short Version (Q-LES-Q)(At intake and 6 times during the treatment (weeks 1, 2, 4, 8, 12, 16))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sigal Zilcha Mano

Associate Professor

University of Haifa

研究点 (1)

Loading locations...

相似试验

Supportive-Expressive and Emotion-Focused Treatment... | 临床试验